Recordkeeping / Reporting. Each Credit Party and, to the Knowledge of Parent, each of its Subsidiaries, has maintained records relating to the research, development, testing, manufacture, production, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export and sale or lease of Product in compliance in all material respects with FDA Laws and other applicable Requirements of Law, and each Credit Party and, to the Knowledge of Parent, each of its Subsidiaries, has submitted to the FDA and other Governmental Bodies in a timely manner all notices and annual or other reports required to be made by it, including adverse experience reports and annual reports, for Product save to the extent that could not reasonably be expected to have a materially adverse impact on such Credit Party’s or Subsidiary’s rights in respect of the Product.
Recordkeeping / Reporting. The Affiliate will respond in a timely manner to reasonable and necessary requests for records or information from SNA, and on an annual basis will provide the following information to SNA headquarters by the following deadlines: • Confirm Affiliate dues amounts by September 30 • Submit updated Affiliate Bylaws by September 30 • Submit an Annual Plan of Action by December 15 • Submit Affiliate delegates for the Delegate Assembly to SNA by May 31 • Submit an Affiliate Year-End Report to SNA by May 31 • Submit an Affiliate Leadership Directory, including the names and contact information of the incoming State Board of Directors, to SNA by May 31 • Submit all available information (date, location, contact person) for annual State conferences for the next three years to SNA by May 31 • Affiliate will inform SNA of all approved changes to Affiliate membership dues at least 3 months prior to the date the new dues would go into effect, so that any changes may correspond with the SNA schedule of dues increase notices to members. Additionally, Affiliate will allow a three-month grace period to members during which the prior year’s dues will still be accepted. SNA will confirm state membership dues changes with the Affiliate and send the Affiliate an updated version of the membership application electronically. SNA will also post the Affiliate membership application on the SNA website. • SNA will be flexible on the deadlines listed above for those Affiliates which transition to new Boards each year at a different time than SNA.
Recordkeeping / Reporting. Praxis and Ionis will prepare and maintain complete and accurate records regarding their respective activities under the Research Plan. At each meeting of the JSC, or if otherwise requested by a Party, each Party will deliver a written report to the other (along with any requested copies of data or reports) describing the activities conducted by such Party under the Research Plan.
Recordkeeping / Reporting. Each Credit Party and, to the Knowledge of Borrower, each of its Subsidiaries has maintained records relating to the research, development, testing, manufacture, production, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export and sale of each of the Products in compliance in all material respects with FDA Laws, DEA Laws and other applicable Requirements of Law, and each Credit Party and, to the Knowledge of Borrower, each of its Subsidiaries has submitted to the FDA and other Governmental Bodies in a timely manner all notices and annual or other reports required to be made by it, including adverse experience reports and annual reports, for each of the Products.
Recordkeeping / Reporting. Except as could not, whether individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, within the past five (5) years, each Credit Party and, to the Knowledge of Borrower, each of its Subsidiaries, has maintained records relating to the research, development, testing, manufacture, recall, production, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export and sale of Product in the Territory in compliance with applicable FDA Laws, Health Care Laws and other applicable Requirements of Law (and any applicable foreign equivalents), and each Credit Party and, to the Knowledge of Borrower, each of its Subsidiaries, has submitted to the FDA and other Governmental Authorities in a timely manner all notices and annual or other reports required to be made by it, including any required adverse experience reports and annual reports, for Product in the Territory.
Recordkeeping / Reporting. Franchisee shall make available to Franchisor for review annual reports regarding the services provided under this Agreement. The Franchisor shall have the right, during normal business hours and upon reasonable (at least three (3) business days') advance notice given to Franchisee by the Franchisor, to inspect the records of Franchisee to ensure compliance with the services provided under this Agreement. Franchisee shall maintain billing records, customer lists, compliance records, and customer complaints for a period of two (2) years or as required by law, whichever is the greater.
Recordkeeping / Reporting. Each Supplier site must comply with record-keeping, data-transmission, incident-reporting, and audit requirements set out in Section 4 of this Exhibit.
Recordkeeping / Reporting. Each Credit Party and, to the Knowledge of such Credit Party, each of its Subsidiaries, has maintained records relating to any aspect of the research, development, testing, manufacture, recall, production, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export and sale of Product in the Territory in compliance in all material respects with FDA Laws, EU Laws, Japanese Laws, Health Care Laws and other applicable Requirements of Law, and each Credit Party and, to the Knowledge of such Credit Party, each of its Subsidiaries, has submitted to the FDA (or foreign equivalents) and other Governmental Authorities in a timely manner all material notices and annual or other reports required to be made, including adverse experience reports, annual reports (including annual reports specific to holders of Orphan Drug designation), and safety reports (including post-marketing safety reports for combination products) required to be made for Product.
Recordkeeping / Reporting. Each Credit Party and, to the Knowledge of such Credit Party, each of its Subsidiaries, has maintained records relating to the research, development, testing, manufacture, recall, production, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export and sale of Product in compliance in all material respects with FDA Laws, Health Care Laws and other applicable Requirements of Law, and each Credit Party and, to the Knowledge of such Credit Party, each of its Subsidiaries, has submitted to the FDA and other Governmental Bodies in a timely manner all notices and annual or other reports required to be made by it, including adverse experience reports and annual reports (including annual reports specific to holders of Orphan Drug designations), for Product save to the extent that could not reasonably be expected to have a materially adverse impact on such Credit Party’s or Subsidiary’s rights in respect of Product.
Recordkeeping / Reporting. ACCESS 3. ZÁZNAMY, VÝKAZY, PŘÍSTUP
